An Open Label pH Comparison of Esomeprazole and Lansoprazole in Barrett's Esophagus Patients

NCT ID: NCT00352261

Last Updated: 2009-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2007-04-30

Brief Summary

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The purpose of the study is to compare the treatment of esomeprazole 40 mg once daily and lansoprazole 30 mg once daily in controlling intragastric pH in Barrett's Esophagus patients

Detailed Description

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Conditions

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Barrett's Esophagus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Esomeprazole

Intervention Type DRUG

Lansoprazole

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Documented history (within 2 yrs of histologically proven BE;
* Aged 18-70 (inclusive);
* Willing and able to comply with all study procedures

Exclusion Criteria

* Signs of clinically significant GI bleeding within 3 days prior to randomization;
* History of gastric or esophageal surgery;
* Clinically significant illness within 2 weeks prior to first dose of study drug or during study
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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Debra Silberg, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Phoenix, Arizona, United States

Site Status

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Tucson, Arizona, United States

Site Status

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North Chicago, Illinois, United States

Site Status

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Rochester, Minnesota, United States

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Research Site

Kansas City, Missouri, United States

Site Status

Research SIte

Springfield, Missouri, United States

Site Status

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Butte, Montana, United States

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Research Site

Cleveland, Ohio, United States

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Philadelphia, Pennsylvania, United States

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Knoxville, Tennessee, United States

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Dallas, Texas, United States

Site Status

Research Site

Norfolk, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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D9612L00082

Identifier Type: -

Identifier Source: org_study_id

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